Officials of the Department of Health and Human Services have long intended to issue this month a number of rules to implement major provisions of the HITECH Act within the American Recovery and Reinvestment Act. Publication on Dec. 7 of HHS' semi-annual regulatory agenda shows the anticipated schedule hasn't changed.

The agenda also lists the dates for starting Medicare incentive programs as Oct. 1, 2010, for hospitals and Jan. 1, 2011, for physicians. This could be an indication that the start dates for incentives for the meaningful use of electronic health records are not slipping.

The semi-annual regulatory agenda identifies actions the department intends to take. Deadlines for anticipated actions are not always accurate. But in the updated agenda, the following HITECH rules remain scheduled for publication in December 2009:

* RIN: 0991-AB58, an Interim Final Rule with comment period to establish an initial set of data standards, implementation specifications and criteria for certification of electronic health records;
* RIN: 0991-AB59, An Interim Final Rule with comment period establishing certification programs for health information technology; and
* RIN: 0938-AP78, a Proposed Rule to establish policies and procedures for the Electronic Health Record Incentive Program under Medicare and Medicaid, including definitions for the meaningful use of EHRs.

Proposed rules to implement enhancements to the HIPAA privacy rule under HITECH also are on the near-term agenda.

HHS' Office for Civil Rights is on tap during December to publish a proposed rule governing business associates, restrictions on certain disclosures and sale of health information, breach notifications, improved health privacy education, and enhanced enforcement of the privacy rule, among other provisions.

ONC, according to the regulatory agenda, remains on schedule to publish a proposed rule in February to implement new privacy rule provisions to account for disclosures of protected health information.

Other expected rulemaking includes:

* A Health Resources and Services Administration final rule in December to require that each state has in effect a system of reporting, to the National Practitioner Data Bank, of disciplinary licensure actions against health care practitioners and entities.
* A Food and Drug Administration proposed rule in March 2010 to require electronic package inserts for human drug and biological products to ensure up-to-date safety and efficacy information.
* A FDA proposed rule in June 2010 to require standards-based electronic submission of data from studies evaluating human drugs and biologics.
* A FDA proposed rule in September 2010 to require electronic registration and listing of medical devices.

Two other long-delayed rules are still pending, with dates for future action still undetermined. They are establishment of a unique identification system for medical devices, and standards for the electronic claims attachments transaction.

The HHS semi-annual regulatory agenda is available at http://reginfo.gov. Click on Current and Past Agendas, and select Department of Health and Human Services in the search box.

--Joseph Goedert

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